Identity
- Trade Name
- Redfield IRC 2100 FDA UDI
- Generic Name
- Infrared tissue coagulation system handpiece FDA UDI
- Device Name
- Contact Tip/Sheath FDA UDI
- Model / Reference
- RIRC-DT6120 FDA UDI
- Description
- Contact Tip/Sheath FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937013245 FDA UDI
- 510(k) Number
- K974168 FDA UDI
- FDA Product Code
- KNS FDA UDI
- GMDN Term
- Infrared tissue coagulation system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 120 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
Category: Infrared tissue coagulation system handpiece
Redfield IRC 2100 by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infrared tissue coagulation system handpiece.
- Redfield IRC 2100 — CooperSurgical, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 8884d132-e50a-4ca8-a319-47cc6a008d3a 35 fields · synced Jun 9, 2026